Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Global, Randomized, Phase 3, Open-Label Study of REGN2810 (Anti-PD-1 Antibody) versus Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic PD-L1 + Non-Small Cell Lung Cancer

This research study is for people with advanced non-small cell lung cancer that has a specific protein called PD-L1. It's comparing a new experimental drug, REGN2810 (also known as Libtayo), to common chemotherapy treatments. Scientists want to find out if the new drug is better at helping people live longer and slowing down the cancer's growth. They will also look at whether the cancer shrinks, how long any improvements last, and how the treatments affect a person's quality of life and side effects. By understanding these things, doctors hope to find better ways to treat this type of lung cancer for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

26 Sep 2024

Non-small Cell Lung Cancer

What is this study about?

This study is designed for individuals diagnosed with advanced non-small cell lung cancer. This is a type of lung cancer that has either spread to other parts of the body (metastatic) or is at a very late stage. Importantly, the cancer must also have a specific marker on its cells called PD-L1. This marker helps doctors understand how the cancer might respond to certain treatments.

The main goal of this study is to compare a new drug, REGN2810 (also known as Libtayo), with standard chemotherapy treatments that are already used for this type of cancer. REGN2810 is a type of drug that works with your body's immune system to fight cancer. The researchers want to see if REGN2810 can help people live longer and stop their cancer from growing for a longer time compared to chemotherapy. They will also be looking at other important aspects like side effects, how the treatments affect your daily life and well-being, and if the cancer shrinks.

By carefully studying these different aspects, doctors hope to determine if REGN2810 could be a more effective treatment option for people with this specific type of advanced non-small cell lung cancer. The information gathered from this study will help improve future care and treatment choices for patients in the UK and worldwide.

Key takeaways

This study is comparing a new drug to standard chemotherapy for advanced non-small cell lung cancer.
It's for people whose cancer has a specific protein called PD-L1.
Researchers want to see if the new drug helps people live longer and stops cancer growth more effectively.
Side effects and quality of life will be carefully monitored.
Participation will involve regular hospital visits for treatment and check-ups.

Who may be eligible?

This study is looking for adults aged 18 or older. It is open to both men and women.

To be considered for this study, you must have advanced non-small cell lung cancer. This means your cancer has either spread to other parts of your body or is at a late stage. Your doctor will also need to confirm that your cancer cells have a specific protein called PD-L1.

There will be other medical checks and criteria that your study doctor will discuss with you to ensure this study is a safe and suitable option for your unique health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer (meaning it has spread or is late-stage)?
Has your doctor confirmed that your cancer has the PD-L1 protein?
Are you able to attend regular hospital visits for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to receive either the new drug (REGN2810/Libtayo) or one of the standard chemotherapy treatments. This will be decided randomly, much like flipping a coin. You will receive your assigned treatment as an infusion (given through a drip into your vein) which will require regular visits to the hospital or clinic.

During these visits, the study team will carry out various tests. These include blood tests, body scans to check your cancer, and discussions about how you're feeling and any side effects you might be having. You will also be asked to fill out questionnaires about your quality of life and lung cancer symptoms to help understand how the treatments affect your daily well-being. These assessments will happen throughout the study and during a follow-up period after your treatment ends to monitor your health. The total duration of your participation will depend on how you respond to the treatment and other factors, but it will involve ongoing monitoring.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than current options, or your health might be closely monitored by a specialist team. However, there's no guarantee the new treatment will work for you, and you could experience side effects from any of the medications. These side effects can vary from mild to serious, and the study team will carefully monitor you for them. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia
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Unverified
Poland
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Unverified
Greece
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Unverified
Bulgaria

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. 'Non-small cell' refers to how the cancer cells look under a microscope.

What is PD-L1?

PD-L1 is a protein found on some cancer cells. It can help the cancer hide from your body's immune system. Treatments that target PD-L1 can help the immune system fight the cancer.

What's the difference between experimental drug and chemotherapy?

An experimental drug is a new medicine being tested. Chemotherapy uses strong medicines to kill fast-growing cancer cells and is a standard treatment.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning you and your study doctor will know which treatment you are receiving (the new drug or chemotherapy).

What does 'Phase 3' mean for a study?

Phase 3 means the experimental drug has shown promise in earlier stages and is now being compared to existing standard treatments in a larger group of people to confirm its safety and effectiveness.